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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509002-30-00 | Other Identifier | EU-CT number |
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The study will evaluate the pharmacokinetics (PK) of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants.
This is a single-group study with a duration of up to 8 weeks (maximum of 53 days) including Screening, Period 1, Period 2, Period 3 and Follow-up.
The study will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD6793 and Itraconazole | Experimental | Participants will receive a single dose of AZD6793 on Day 1. On Day 4, the participant will receive 2 doses of 200 mg itraconazole 12 hours apart followed by a single dose of 200 mg itraconazole from Days 5 to 7. On Day 8, participants will receive a combined dose of AZD6793 and 200 mg itraconazole. On Day 9 and Day 10, the participants will receive a single dose of 200 mg itraconazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6793 | Drug | Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma drug concentration (Cmax) | The effect of itraconazole on the single-dose Cmax of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) | The effect of itraconazole on the single-dose AUClast of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Area under plasma concentration-time curve from time 0 to infinity (AUCinf) | The effect of itraconazole on the single-dose AUCinf of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Apparent total body clearance (CL/F) | The effect of itraconazole on the single-dose CL/F of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Terminal elimination half-life (t1/2λz) | The effect of itraconazole on the single-dose t1/2λz of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Time to reach maximum observed concentration (tmax) | The effect of itraconazole on the single-dose tmax of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Apparent volume of distribution during the terminal phase (Vz/F) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The safety and tolerability after administration of AZD6793 with itraconazole will be evaluated. | From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This is an open-label, single-group, 3 period fixed sequence study.
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| Itraconazole | Drug | Participants will receive 2 doses of itraconazole on Day 4 and single dose from Day 5 to Day 7 in Period 2. On Day 8 participants will receive single dose of itraconazole combined with AZD6793 and then single dose of itraconazole from Day 9 to Day 10 in Period 3. |
|
| AZD6793+ Itraconazole | Drug | Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3. |
|
The effect of itraconazole on the single-dose Vz/F of AZD6793 will be evaluated in healthy participants. |
| Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Ratio Area under plasma concentration-time curve from time 0 to infinity (RAUCinf) | The effect of itraconazole on the single-dose RAUCinf of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Ratio Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (RAUClast) | The effect of itraconazole on the single-dose RAUClast of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| Ratio Maximum plasma drug concentration (RCmax) | The effect of itraconazole on the single-dose RCmax of AZD6793 will be evaluated in healthy participants. | Post-dose on Day 1 to Day 3; and Day 8 to Day 11 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010879 |
| Piperazines |